SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE

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SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE

Brief description of study

The purpose of this program is to assess the safety and efficacy of upadacitinib compared with placebo (fake drug) for the treatment of signs and symptoms in adults with moderately to severely active systemic lupus erythematosus (SLE). Upadacitinib is an experimental drug that blocks the actions of proteins known as Janus kinases (Jaks). Jaks are involved in the immune response and cell growth including blood cells.

The study drug has been approved by regulatory authorities to treat other medical conditions such as rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis but is not approved to treat lupus. Therefore, the use of the study drug is investigational (experimental) for the purposes of this program.

Clinical Study Identifier: s23-00460

ClinicalTrials.gov Identifier: NCT05843643

Principal Investigator: Amit Saxena.

Other Investigator: Janine M. Sullivan.

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